Methods: Patients aged ≥ 18 years with confirmed advanced RCC diagnosis, ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Karnofsky Performance Status ≥ 70, controlled blood pressure, and adequate blood coagulation, renal, hepatic, and bone marrow function are eligible. Patients will be randomized 1:1:1 to receive LEN 18 mg/d + EVE 5mg/d, LEN 20 mg/d + PEM 200 mg every 3 weeks, or SUN 50 mg/d (on a schedule of 4 weeks on treatment followed by 2 weeks off) until disease progression, unacceptable toxicity, withdrawal of consent, or study end.
The planned primary endpoint is to demonstrate superiority of LEN+EVE or LEN+PEM over single-agent SUN as first-line treatment for advanced RCC in improving progression free survival (PFS). Furthermore, secondary endpoints will include comparison of objective response rate, overall survival, PFS on next-line therapy, health-related quality of life, and safety and tolerability in receiving LEN+EVE or LEN+PEM vs SUN.
Lastly, exploratory endpoints will include PFS in the LEN+PEM arm using immune-related RECIST, comparison of duration of response, disease control rate, and clinical benefit rate in pts treated with LEN+EVE or LEN+PEM vs SUN, and analysis of the relationship between blood biomarkers and outcome. The authors plan to enroll 735 patients to achieve 90% power at 2-sided α = 0.05 to detect a difference in ≥ 1 of the primary comparisons.
Presented by: Robert J. Motzer, New York, USA
Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre, @GoldbergHanan, at the 18th Annual Meeting of the Society of Urologic Oncology, November 29-December 1, 2017 – Washington, DC